NDC 71672-030 Hi Hand Clean

Hypochlorous Acid

NDC Product Code 71672-030

NDC 71672-030-01

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC Product Information

Hi Hand Clean with NDC 71672-030 is a a human over the counter drug product labeled by Eco Face Shop. The generic name of Hi Hand Clean is hypochlorous acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Eco Face Shop

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Hi Hand Clean Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYPOCHLOROUS ACID .015 g/500mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHOL (UNII: L7T10EIP3A)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • WATER (UNII: 059QF0KO0R)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Eco Face Shop
Labeler Code: 71672
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hi Hand Clean Product Label Images

Hi Hand Clean Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Hypochlorous Acid 0.003%

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf powder, Butylene Glycol, Carbomer, Citrus Limon(Lemon) Peel Oil/ Limonene, Citral, Glycerin, L-Arginine, Melaleuca Alternifolia(Tea Tree)Leaf Extract, Menthol, Niacinamide, Water, 1,2-Hexanediol

Purpose

Antiseptic and skin protection

Warnings

For external use only.--------------------------------------------------------------------------------------------------------Do not use• in childre  n less than 2 months of age• on open skin wounds--------------------------------------------------------------------------------------------------------When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.--------------------------------------------------------------------------------------------------------Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

• instant hand antiseptic to decrease bacteria on the skin

Directions

• Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.• Supervise children in the use of this product.

Other Information

• Store between 15-30C (59-86F)• Avoid freezing and excessive heat above 40C (104F)• Avoid UV rays• Notice by fair trade commission in case of any abnormality in this product we •Manufacturing date and period of use : three years from date of manufacture

* Please review the disclaimer below.